Weekly Roundup – 09/10/10

September 10, 2010

For a short week, it seemed like a long one. And you can tell by my few posts this week, it was a busy one. Here in Washington, we immediately turned a climate corner with the Labor Day holiday and we have enjoyed an incredible week of blue skies, low humidity and moderate temperatures that allow for turning of air conditioners and enjoying breezes that are nothing short of delicious.

And for the serious stuff that happened, well here is some of it:

FDA Flip Flops on Drug Withdrawal – The New York Times reported that after setting its cap to withdraw the drug midodrine from the market due to the fact that studies to affirm efficacy of the compound, approved under accelerated approval conditions, were never performed. An outcry from patients who use the drug, however, appears to have caused a re-visitation of the matter and the drug is not being withdrawn pending more data. It appears that actual use by patients wins the day.

FDA Moves Another PDUFA Date - And speaking of changing your mind, a few weeks ago, I posted an article about FDA and the circumstances by which PDUFA dates can be changed, citing a recent episode with Eisai. Well this week there was another announced by QuestCor for an sNDA for H.P.Acthar Gel for use in infantile spasms. The statement by company said the FDA needed more time to work on the label, review the medication guide and to define what, if any, post approval commitments are necessary.

Agency Issues Warning on e-Cigarettes- For some time, there has been a brouhaha brewing over e-cigarettes. What the heck is an e-cigarette, you ask? It is a battery powered device to deliver vapor through inhalation – and the vapor may or may not contain nicotine. This week the FDA sent a Warning Letter to five manufacturers of these devices citing them for unsubstantiated claims and for certain manufacturing processes. But the language I thought was most interesting was this. "The scientific and medical communities have determined that nicotine is pharmacological agent, that nicotine addiction is a disease, and that nicotine withdrawal is itself a recognized medical condition." The letter goes further to say that by marketing the e-cigarette as a device to help smokers quit, they are seeking to treat a disease which means that the products are misbranded and have not been covered by an application for approval before the FDA.

FDA Notes Caution About Over-reacting to Meta Analyses - Matthew Herper at Forbes pointed out in a post this week a passage this week from the New England Journal of Medicine where the agency points out that while there are increasing meta-analyses of drugs coming out which may raise safety questions, that the entire picture needs to be examined in assessing safety. It was certainly refreshing reading in our climate of extreme risk aversion. Here is what they said: "We have entered an era of increasingly frequent publication of meda-analyses, some of which identify potential safety signals. Such publication commonly leads to urgent calls to take immediate regulatory action, without acknowledgment of the potential pitfalls in the interpretation of data from meta-analyses and pooled analyses … We must use measured restraint during our evaluations to ensure that safe drugs remain on the market and that their use is not restricted in a way that unnecessarily denies beneficial interventions to patients who need them. The continuing evaluation of potential safety signals at the FDA requires assessment of all available data from many sources, with the goal of reaching sound conclusions in a manner that is transparent to physicians and patients." Thanks MH for pointing out.

Stay Connected

About This Blog

Eye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.